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Showing 15 posts of 1442 posts found.

FDA advisory committee recommends approval of Remicade biosimilar

February 10, 2016
Research and Development, Sales and Marketing FDA, Pfizer, Remicade, biosimilar, celltrion

An FDA advisory panel yesterday voted overwhelmingly in favour of approving CT-P13- Celltrion’s biosimilar version of Johnson&Johnson’s blockbuster arthritis drug …

News
Shkreli hearing

Big pharma answers tough questions at US drug pricing hearing

February 5, 2016
Medical Communications Drug pricing, FDA, Martin Shkreli, Senate, Turing Pharmaceuticals, US, Valeant, congress

Pharmaceutical industry executives came under intense scrutiny at a Congressional hearing in the US as the debate over the spiralling …

News
Lundbeck HQ

Lundbeck gets go-ahead for US and EU licence expansions

February 4, 2016
Medical Communications, Sales and Marketing Abilify, EMA, FDA, Lundbeck, Otsuka, Takeda, aripiprazole, brintellix, vortioxetine

Lundbeck has earned two recommendations from regulatory committees of the FDA and the EMA, which both recommended the company’s drugs …

News
Merck image

MSD gets FDA approval for hepatitis C drug Zepatier

January 29, 2016
Medical Communications, Sales and Marketing FDA, MSD, Zepatier, hepatitis C

The competitive hepatitis C market is to get another contender, with FDA approving MSD’s new combo treatment Zepatier (elbasvir and …

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clinical trial patient

FDA plans greater diversity in clinical trials

January 29, 2016
Medical Communications, Research and Development FDA, Robert Califf, clinical trial, patient recruitment

The FDA is to focus on increasing patient diversity in clinical trials in 2016, to “ensure that research participants are …

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Lynparza

AZ’s Lynparza gets prostate cancer breakthrough status

January 28, 2016
Sales and Marketing AstraZeneca, Breakthrough Therapy Designation, FDA, lynparza, olaparib, prostate cancer

AstraZeneca’s Lynparza has been granted breakthrough therapy designation by the FDA as a monotherapy for the treatment of a specific …

News
Jardiance

FDA reviews Jardiance as cardiovascular diabetes treatment

January 27, 2016
Research and Development, Sales and Marketing Boehringer Ingelheim, Eli Lilly, FDA, jardiance

The FDA has accepted Boehringer Ingelheim and Eli Lilly’s supplemental New Drug Application for their diabetes drug Jardiance to be …

News
Amgen image

FDA to review Amgen’s Humira biosimilar

January 26, 2016
Manufacturing and Production ABP-501, Amgen, FDA, biosimilar

The FDA has accepted for review Amgen’s Biologics License Application (BLA) for ABP 501, a biosimilar candidate to AbbVie’s Humira …

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shire_image

Shire tries again with lifitegrast dry eye FDA application

January 25, 2016
Manufacturing and Production, Sales and Marketing FDA, Shire, dry eye disease, lifitegrast

Shire has resubmitted its New Drug Application (NDA) to the US FDA for its rejected dry eye syndrome drug lifitegrast. …

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J&J image

Patients sue J&J for $800m for ‘hiding antibiotic side effects’

January 22, 2016
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Janssen, Johnson and Johnson, Levaquin, Margaret Hamburg, lawsuit, levofloxacin

Six users of Johnson & Johnson’s antibiotic Levaquin are to sue the company for up to $870 million, claiming the …

News
Amgen image

FDA approves new Kyprolis combo for multiple myeloma

January 22, 2016
Medical Communications, Sales and Marketing Amgen, FDA, Kyprolis, carfilzomib, multiple myeloma, myeloma

Amgen’s Kyprolis has been given another endorsement by the FDA as a multiple myeloma treatment – its second in six …

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FDA logo

AbbVie/Roche’s venetoclax bags FDA Breakthrough Therapy Designation

January 21, 2016
Sales and Marketing AbbVie, Breakthrough Therapy Designation, FDA, Roche, venetoclax

AbbVie and Roche’s cancer drug venetoclax has been granted Breakthrough Therapy Designation by the FDA in combination with rituximab for …

News
eli_lilly_logo

Lilly awaits FDA review of new arthritis treatment

January 20, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Eli Lilly, FDA, Incyte, NDA, baricitinib, lilly, new drug application, rheumatoid arthritis

Eli Lilly has submitted a new drug application (NDA) to the FDA for baricitinib as a treatment for moderate-to-severe rheumatoid …

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Arzerra

Arzerra approved by US FDA for leukaemia

January 20, 2016
Research and Development, Sales and Marketing Afrezza, CLL, FDA, Genmab, Novartis, chronic lymphocytic leukaemia, ofatumumab, sBLA, supplementary biologics license application

The FDA has signed-off a supplemental Biologics License Application (sBLA), meaning Arzerra is approved for extended treatment of patients who …

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Eisai logo

FDA grants Eisai’s Lenvima priority review for kidney cancer

January 19, 2016
Manufacturing and Production Breakthrough Therapy Designation, Eisai, FDA, Kidney cancer, Lenvima, lenvatinib, priority review, renal cell carcinoma

The FDA has accepted Eisai’s supplemental New Drug Application (sNDA) for its anti-cancer agent Lenvima for use in the treatment …

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